Leukemia, Myeloid Clinical Trial
Official title:
Phase 2 Study of Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
NCT number | NCT01050036 |
Other study ID # | AMC-H-54 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | December 2018 |
Primary study objective is the evaluation of efficacy of autologous hematopoietic cell
transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in
the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and
disease-free survival (DFS).
Secondary study objectives are the engraftment rate / time to engraftment,
transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall
survival (OS).
Status | Recruiting |
Enrollment | 39 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFa2T1)], inv(16)(q13q22) (CBFß/MYH11), t(16;16)(p13;q22) (CBFß/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique. - Patients who plan to receive the second cycle of HDAC consolidation chemotherapy. - 15 years old or older and 65 years or younger - Adequate performance status (Karnofsky score of 70 or more). - Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL). - Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography) - Signed and dated informed consent must be obtained from patient. Exclusion Criteria: - Presence of significant active infection - Presence of uncontrolled bleeding - Any coexisting major illness or organ failure - Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible - Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception - Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | Kyeongki-do |
Korea, Republic of | Busan Paik Hospital, Inje University College of Medicine | Busan | |
Korea, Republic of | Kosin University, Gospel Hospital | Busan | |
Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
Korea, Republic of | Daegu Fatima Hospital | Daegu | |
Korea, Republic of | Yeongnam University Hospital | Daegu | |
Korea, Republic of | Wonkwang University Hospital | Iksan | Chollabuk-do |
Korea, Republic of | Gachon University Gil Hospital | Inchon | |
Korea, Republic of | Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Ulsan University Hospital, University of Ulsan College of Medicine | Ulsan |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cumulative incidence of relapse | cumulative incidence of relapse | 3 years | |
Secondary | Disease-free survival | defined as the interval between the day when complete remission is confirmed with bone marrow biopsy report (not by the day when bone marrow biopsy was performed) and the day when the relapse is confirmed by bone marrow biopsy or the presence of peripheral blood. | 3 years | |
Secondary | engraftment rate | defined as the interval between day 0 (PBSCs infusion) and the first day of evidence for engraftment. | 100 days | |
Secondary | transplantation-related mortality | transplantation-related mortality | 100 days | |
Secondary | Event-free survival | defined as the interval between day 0-PBSCs infusion and the event. | 3 years | |
Secondary | Overall survival | measured from day 0 to the date of last follow-up or death. | 3 years |
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